WOLF SICKLE KNIFE WOLF 8211.90 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-04-17 for WOLF SICKLE KNIFE WOLF 8211.90 * manufactured by Richard Wolf Med Instruments Corp..

Event Text Entries

[15613155] A 39 year old male in outpatient surgical ctr maxillary and left sphenoid sinus surgery, septoplasty and nasal tip plasty. While md using the sickle knife in the nose, snap heard, when instrument removed from the nose, the md & scrub noticed a portion of the blade missing from the handle. Surgeon unable to locate the blade visually and x-ray done immediately. Located tip and md removed piece of blade. At that time a cerebrospinal fluid leak was noted from the area of the cribri-form plate. Md attempted to seal/patch leak but leak continued and pt admitted to another facility for lumbar drain placement for diversion and observation.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 163277
• MDR Report Key: 163277
• Date Received: 1998-04-17
• Date of Report: 1998-04-15
• Date of Event: 1998-04-09
• Date Facility Aware: 1998-04-09
• Report Date: 1998-04-15
• Date Reported to FDA: 1998-04-15
• Date Added to Maude: 1998-04-21
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: WOLF SICKLE KNIFE
• Generic Name: SICKLE KNIFE- SHARP
• Product Code: KTG
• Date Received: 1998-04-17
• Model Number: WOLF 8211.90
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 158947
• Manufacturer: RICHARD WOLF MED INSTRUMENTS CORP.
• Manufacturer Address: 353 CORPORATE WOODS PKWY VERNON HILLS IL 60061 US
• Baseline Brand Name: SICKLE KNIFE
• Baseline Generic Name: SICKLE KNIFE
• Baseline Model No: 8211.90
• Baseline Catalog No: 8211.90
• Baseline ID: NA
• Baseline Device Family: ENT KNIFE
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: N
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: Y

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	1998-04-17